Sue Desmond-Hellmann, AP Images

Sue Desmond-Hell­mann says it's time for her to leave the Gates Foun­da­tion. Strat­e­gy chief Mark Suz­man will now take the helm

Su­san Desmond-Hell­mann, the long­time re­searcher and ex­ec­u­tive who helped lead Genen­tech to de­vel­op the first gene-tar­get­ed can­cer ther­a­pies, is step­ping down af­ter 5 years as CEO of the Bill & Melin­da Gates Foun­da­tion.

Step­ping down as CEO of@Gates­Foun­da­tion is, with­out a doubt, the tough­est de­ci­sion of my ca­reer,” she wrote in the first of a se­ries of tweets an­nounc­ing and re­flect­ing on her de­par­ture. “But one of my mantras is ‘take your own pulse first.’ Over the last few months, I’ve done just that and con­clud­ed that I need to slow down.”

Mark Suz­man

Mark Suz­man, the foun­da­tion’s pres­i­dent of Glob­al Pol­i­cy & Ad­vo­ca­cy and chief strat­e­gy of­fi­cer, will now take over as the new CEO. Suz­man joined the foun­da­tion 12 years ago and takes the new role of­fi­cial­ly on Feb­ru­ary 1, 2020.

Desmond-Hell­mann was named CEO of the mas­sive char­i­ty in 2013, af­ter years at the top of Genen­tech and a stint as the first woman chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co. She was the first physi­cian to lead the foun­da­tion and dur­ing her tenure launched what was billed as the first non­prof­it biotech, the Gates Med­ical Re­search In­sti­tute, a move she re­called as one of her top achieve­ments.

Re­cent­ly, the long­time re­searcher cut down on work out­side the foun­da­tion and said to­day she was leav­ing to fo­cus on her­self and her fam­i­ly.

Desmond-Hell­mann got her start in med­i­cine as a kid, hang­ing around and some­times book­keep­ing at the drug­store her par­ents owned in Reno, Neva­da. In lat­er years, she talked about how watch­ing her fa­ther in­ter­act kind­ly with the peo­ple who came in made her want to be­come a doc­tor. Af­ter she grad­u­at­ed from the Uni­ver­si­ty of Neva­da, she took an in­tern job at UCSF in 1982, her for­ma­tive years as a physi­cian spent at the be­gin­ning and cen­ter of the AIDS/HIV cri­sis. Af­ter sev­er­al years work­ing on the virus and Ka­posi’s sar­co­ma, she and her hus­band — Nicholas Hell­mann, al­so a young UCSF doc­tor — moved to Ugan­da to do sim­i­lar work.

“We were ap­proached by the Rock­e­feller Foun­da­tion to study het­ero­sex­u­al HIV trans­mis­sion in Africa, so my hus­band Nick and I sold our Hon­da Civics, sub­let our apart­ment, and hopped on a plane,” she re­called to Reuters in Ju­ly. “We were ex­treme­ly iso­lat­ed. When we came back from Ugan­da, we nev­er com­plained about any­thing ever again.”

She fell in­to drug de­vel­op­ment two years af­ter they re­turned to Nicholas’ home state of Ken­tucky, when they both took po­si­tions at Bris­tol-My­ers Squibb in Con­necti­cut in 1993. She worked on Tax­ol, a chemother­a­py drug orig­i­nal­ly de­rived from Pa­cif­ic yew bark and first FDA-ap­proved short­ly be­fore her ar­rival.

“It was like I had been train­ing my whole life for that job,” Desmond-Hell­mann told the New York Times in 2011.

At the time, Genen­tech hadn’t de­vel­oped any can­cer drugs. The lega­cy biotech brought Desmond-Hell­mann back to San Fran­cis­co in 1995 to help build that pipeline and pro­mot­ed her to chief med­ical of­fi­cer the fol­low­ing year.

Arthur Levin­son, the CEO of Genen­tech dur­ing her tenure, de­scribed her to the New York Times as a shrewd ex­ec­u­tive, who was able to use her on­col­o­gy and sta­tis­ti­cal back­ground to choose the best drugs — and was al­so able to tell re­searchers when their projects weren’t be­ing cho­sen.

“She’s a very nice per­son, so this did not come nat­u­ral­ly to her,” Levin­son said. “But she got it quick­ly. She be­came a tough leader, tough in a pos­i­tive sense. She was will­ing to make tough calls with­out much dif­fi­cul­ty.”

Over 14 years at Genen­tech, she over­saw the de­vel­op­ment of Avastin and Her­ceptin, the first gene-tar­get­ed can­cer ther­a­pies.

She left the com­pa­ny when it was bought out by Roche in 2009, leav­ing as head of prod­uct de­vel­op­ment, and soon went on to be­come chan­cel­lor of UCSF (where there was a brief con­tro­ver­sy over her to­bac­co in­vest­ments, which she im­me­di­ate­ly sold off.). She joined the Gates Foun­da­tion in 2014.

As CEO she over­saw a bevy of pub­lic health pro­grams and, in 2018, the launch of the Gates Med­ical Re­search In­sti­tute in Cam­bridge, MA, lur­ing ex­ec­u­tives from No­var­tis and Mer­ck and oth­er top biotech firms to fill out the lead­er­ship team.

The in­sti­tute launched with a bud­get of $100 mil­lion and tar­gets the Gates Foun­da­tion had long pur­sued: malar­ia, tu­ber­cu­lo­sis, and di­ar­rheal dis­eases. The idea was to help di­rect­ly de­vel­op drugs that the mar­ket wasn’t in­cen­tiviz­ing, in­clud­ing a malar­i­al vac­cine. Their first big project is test­ing if a boost­er shot of Bacil­lus Cal­mette-Guérin, the tu­ber­cu­lo­sis vac­cine al­ready giv­en to in­fants, could help im­prove im­mu­ni­ty for ado­les­cents.

“What keeps me awake is we have all this cap­i­tal, we have all this op­por­tu­ni­ty and we bet­ter get some­thing done,” Desmond-Hell­mann told Forbes last year. “We bet­ter do some good in the world, or I will not feel good about lead­ing in the Gates Foun­da­tion.”

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.